Back to resultsTechnology-Based Prevention for Adolescents in Primary Care
Primary Purpose
Substance Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use focused on measuring adolescents, primary care, sexual assault, substance use, sexual risk behavior
Eligibility Criteria
Inclusion Criteria:
- Aged 14-18
- Recent visit to primary care doctor
Exclusion Criteria:
- Inability to comprehend English independently due to disability or language
Sites / Locations
- Georgia State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control
Arm Description
Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Assessment only control.
Outcomes
Primary Outcome Measures
Enrollment and recruitment rate
Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study
Retention Rate
Feasibility of retention was assessed by the proportion of participants retained in the study
Secondary Outcome Measures
Full Information
NCT ID
NCT03489434
First Posted
March 29, 2018
Last Updated
February 22, 2023
Sponsor
Georgia State University
1. Study Identification
Unique Protocol Identification Number
NCT03489434
Brief Title
Technology-Based Prevention for Adolescents in Primary Care
Official Title
Technology-Based Prevention for Adolescents in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
October 3, 2022 (Actual)
Study Completion Date
October 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public health concern, and subsequently there is also a great need to prevent these behaviors and experiences. This project involves the adaptation and integration of evidence-based prevention content aimed at preventing and reducing substance use, sexual assault, and sexual risk behaviors. This project uses innovative technology within primary care visits to conduct a feasibility trial of an integrated prevention program.
Detailed Description
Pilot feasibility trial in preparation for RCT. Adolescents aged 14-18 will be recruited for screening from community-based primary care clinics to ensure ease of dissemination and representation of community-based primary care settings. The primary goal is to develop feasibility to apply for an R01 to conduct an RCT. Power analyses indicate that 280 participants would be needed for an RCT after accounting for attrition. Given that the RCT would be conducted over a 3-year period, a recruitment rate of 8 adolescents per month would indicate feasibility for a larger RCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
adolescents, primary care, sexual assault, substance use, sexual risk behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Participant and Investigator are blinded to condition
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Assessment only control.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
Primary Outcome Measure Information:
Title
Enrollment and recruitment rate
Description
Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study
Time Frame
within 2 year recruitment period
Title
Retention Rate
Description
Feasibility of retention was assessed by the proportion of participants retained in the study
Time Frame
within 6 months of baseline participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 14-18
Recent visit to primary care doctor
Exclusion Criteria:
Inability to comprehend English independently due to disability or language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda K Gilmore, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Technology-Based Prevention for Adolescents in Primary Care
We'll reach out to this number within 24 hrs